The impact of paclitaxel concerns on vascular access

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As part of Wednesday’s CX Vascular Access Workshop in the Pillar Hall Learning Centre, there was a section of the programme on drug-coated balloon trial updates which ended with a panel discussion on whether peripheral vascular disease data is applicable to vascular access. The discussion sparked interest from delegates, with a vote at the end making it clear that physicians want more data in order to determine the place of drug-coated balloons in vascular access, in the light of debate surrounding paclitaxel use in the femoropopliteal artery.

The session had started with Panagiotis Kitrou (Patras, Greece) presenting the latest update on the Lutonix AV Global Registry and investigational device exemption trial, Qizhuang Jin (Beijing, China) the results of a study of haemodialysis arteriovenous fistulae stenosis treated with Aperto, and Andrew Holden (Auckland, New Zealand) discussing baseline data from the full cohort of the IN.PACT AV trial.

Following these presentations and the panel discussion, moderator Nicholas Inston (Birmingham, UK), asked the audience two questions; first, if they will continue to use drug-coated technology in their practice, and second, whether they believe more data is needed. While very few delegates voted for either continuing or ceasing use of drug-coated technology, there was consensus that more data is needed in order to determine the place of drug-coated balloons in vascular access treatment.

The panel was made up of Panagiotis Kitrou, Andrew Holden, Robert Jones (Birmingham, UK), Kate Steiner (Stevenage, UK), Domenico Valenti (London, UK) and Qizhuang Jin. Based on the discussion, it was clear that the Katsanos et al meta-analysis has had an impact on clinical practice in the field of vascular access. Jones, for example, mentioned that in his hospital in Birmingham, UK, a randomised trial on fistulas was “paused” and that drug-coated technology has been removed from the hospital. “I cannot see us starting to use them again any time soon,” he commented.

Holden commented that it was a “shame” that a randomised trial had been stopped, and asked the question: “In what other format would you want to be looking at this than in a clinical trial?”

Steiner had questions about elements missing from the available data. “As well as the older patients that we treat, we do treat young patients who are going to have a transplant and probably are going to do relatively well.” She then asked the the other panellists: “How do we feel about treating that patient population, in which there is a proven benefit? With that population I think it is a bit more of a difficult discussion to have.”

Holden commented: “All you can do is discuss it with patients and say here is the data. I hope that we get more information and that it changes the discussion a bit.”

There was agreement in the room, however, that presenting data to the patient and leaving the final decision up to them often leads to the question “What do you think?” in the hope that they will receive a definitive, straightforward answer.

Kitrou remarked: “There are many assumptions that we can make. We have been discussing this over and over again,” alluding to the fact that the need for new data is becoming increasingly apparent.

At the end of the session, after a show of hands from just about all delegates, Inston conclused that “It looks like people want more data.”

Looking forward, there are upcoming studies on the topic which are randomised controlled trials, some of which are company and others which are investigator initiated.